FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
12961–12984 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 26, 1989
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K894942 · DSP
Boston Scientific Corp
Cardiovascular · 54d
Cleared Sep 26, 1989
MAESTRO PACEMAKER TEST MAGNET
K895110 · DTG
Cardiac Control Systems, Inc.
Cardiovascular · 42d
Cleared Sep 26, 1989
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
K895495 · DXY
Medtronic Vascular
Cardiovascular · 29d
Cleared Sep 22, 1989
HOLTAIN BODY COMPOSITION ANALYSER
K891928 · DSB
Seritex, Inc.
Cardiovascular · 178d
Cleared Sep 21, 1989
SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II
K894103 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 104d
Cleared Sep 20, 1989
10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892797 · DSP
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 20, 1989
9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892798 · DSP
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 20, 1989
8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892799 · DSP
Kontron Instruments, Inc.
Cardiovascular · 156d
Cleared Sep 20, 1989
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
K893459 · DSY
Medtronic Vascular
Cardiovascular · 140d
Cleared Sep 20, 1989
OPUS MODELS 4033 AND 4034
K894267 · DXY
Ela Medical, Inc.
Cardiovascular · 90d
Cleared Sep 20, 1989
MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE
K894981 · DSA
Medtronic Vascular
Cardiovascular · 43d
Cleared Sep 19, 1989
RMI ARTERIAL PERFUSION CANNULA
K894243 · DQR
Research Medical, Inc.
Cardiovascular · 90d
Cleared Sep 18, 1989
CATHETER INTRODUCER SHEATH
K890766 · DYB
Applied Vascular Devices, Inc.
Cardiovascular · 215d
Cleared Sep 18, 1989
TRI-LUMEN INTRA VASCULAR BALLOON CATHETER
K891021 · DXE
Ideal Medical, Inc.
Cardiovascular · 202d
Cleared Sep 18, 1989
DAIG ELECTROPHYSIOLOGY CATHETER
K894500 · DRF
Daig Corp.
Cardiovascular · 61d
Cleared Sep 18, 1989
ASC-952 PHYSIOLOGICAL AMPLIFIER
K894735 · DRR
Astro-Med, Inc.
Cardiovascular · 53d
Cleared Sep 18, 1989
NR5000 E.C.G. AND PULSE OXIMETER MONITOR
K894919 · DRT
Nirad , Ltd.
Cardiovascular · 47d
Cleared Sep 13, 1989
DISP. ACCESSORY TO EXTERNAL TRANS. CARDIAC PACE.
K891122 · LDD
Big Valley Medical
Cardiovascular · 195d
Cleared Sep 13, 1989
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000
K892878 · DSP
Kontron Instruments, Inc.
Cardiovascular · 147d
Cleared Sep 13, 1989
ELECTROTRACE DISP. RESTING EKG ELECTRODES
K894679 · DRX
Jason Marketing Co.
Cardiovascular · 50d
Cleared Sep 13, 1989
MODEL 6888 LEAD TUNNELER
K894738 · DWS
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Sep 12, 1989
GUIDEWIRE
K890959 · DQX
Guidewire Technologies, Inc.
Cardiovascular · 197d
Cleared Sep 12, 1989
OPTIMA MPT AND SPT PACEMAKERS
K891231 · DXY
Telectronics, Inc.
Cardiovascular · 189d
Cleared Sep 12, 1989
DAIG VESSEL DILATOR
K894330 · DRE
Daig Corp.
Cardiovascular · 60d